Robotic Surgical ProceduresSPAROBOPANNCT06899269
SPAROBOPAN Project (Spanish Registry of Robotic Pancreatic Surgery)
An observational study of Robotic Surgical Procedures and Pancreatic Diseases, run by Hospital General Universitario de Alicante.
Trial summary
Pancreatic robotic surgery (PRS) has moved from an almost testimonial procedure to a moment of expansion that is not yet clearly defined. In the pioneering centres, the results achieved are superior to those of open surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Robotic Surgical Procedures, Pancreatic Diseases
- What is being tested?
- robotic resection with Da Vinci Xi
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 30 Jun 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who will undergo robotic pancreatic resections
Who may be able to join
- robotic pancreatic resections
- Asa I-III
- Signed informed consent
Who cannot join
- Less than 18 years old.
- ASA IV
About this study
Official title: Proyecto SPAROBOPAN (Registro Nacional De Cirugía Róbotica Pancreática)
Pancreatic robotic surgery (PRS) has moved from an almost testimonial procedure to a moment of expansion that is not yet clearly defined. In the pioneering centres, the results achieved are superior to those of open surgery. At present, it is not known how many centres perform CRP, what type of operations they perform, what percentage of the total number of pancreatic operations CRP represents and what results are obtained. The aim of our project is to establish a national multicentre registry of robotic pancreatic surgery that will allow us to answer all these questions.
Methodology: This is a one-year prospective multicentre registry involving all general and digestive surgery units in Spain that have a DaVinci robotic platform and wish to participate and perform robotic pancreatectomies.
All adult patients undergoing robotic pancreatectomy at participating Spanish centres who meet the inclusion criteria will be included. The registry will be open until 31 March 2026 to include post-operative morbidity and mortality at 90 days. The number of pancreatic surgeries performed in that centre during the same period will be counted to determine the percentage of robotic pancreatic surgery per centre. Intraoperative complications will be measured according to the Satava classification modified by Halls et al. Postoperative complications will be classified according to the Clavien-Dindo classification and the CCI (Comprehensive Complication Index). Pancreatic fistula, postoperative bleeding and delayed gastric emptying were classified according to the ISGPS classification and biliary fistula according to the ISGLS classification.
- Conditions
- Robotic Surgical Procedures, Pancreatic Diseases
- Being tested
- robotic resection with Da Vinci Xi
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic resection with Da Vinci XiDevice
robotic resection with Da Vinci Xi
| Study group | Role | What they receive |
|---|---|---|
| Duoneopancreatectomy | Resection of the head of the pancreas Receives: Device: robotic resection with Da Vinci Xi | |
| Distal pancreatectomy | Resection of the body and the tail of the pancreas Receives: Device: robotic resection with Da Vinci Xi | |
| Total pancreatectomy | Total removal of the pancreas Receives: Device: robotic resection with Da Vinci Xi | |
| central pancreatectomy | body or neck of the pancreas resection Receives: Device: robotic resection with Da Vinci Xi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Clavien-Dindo Classification
Measured: 90 postoperative days
Postoperative complications
CCI® (Comprehensive Complication Index). 0-100%. 100% represents the death of the patient.
Measured: 90 postoperative days
Number of robotic procedures
Number of robotic pancreatic procedures
Measured: 1 year
Secondary outcomes (4)
Experience of each group in robotic pancreatic surgery
Questonnaire answering the number of robotic procedures in 2024.
Measured: 1 year
Textbook outcome
Composite measure: No reintervention, no major complications, no readmission, no pancreatic leak B/C, no mortality and no prolongued hospital stay
Measured: 1 year
Total survival
survival after surgery in months
Measured: 3 years
Disease-free survival
Time from surgery to recurrence
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario de Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candido Fernando Alcazar-Lopez, Hospital General Universitario de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899269
- Sponsor's protocol ID
- 2024-089
- Acronym
- SPAROBOPAN
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Due to local law with personal data
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proyecto SPAROBOPAN (Registro Nacional De Cirugía Róbotica Pancreática)
- ClinicalTrials.gov ID
- NCT06899269
- Acronym / sponsor ID
- SPAROBOPAN / 2024-089
- Conditions
- Robotic Surgical Procedures, Pancreatic Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Hospital General Universitario de AlicanteUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic robotic surgery (PRS) has moved from an almost testimonial procedure to a moment of expansion that is not yet clearly defined. In the pioneering centres, the results achieved are superior to those of open surgery. At present, it is not known how many centres perform CRP, what type of operations they perform, what percentage of the total number of pancreatic operations CRP represents and what results are obtained. The aim of our project is to establish a national multicentre registry of robotic pancreatic surgery that will allow us to answer all these questions.
Methodology: This is a one-year prospective multicentre registry involving all general and digestive surgery units in Spain that have a DaVinci robotic platform and wish to participate and perform robotic pancreatectomies.
All adult patients undergoing robotic pancreatectomy at participating Spanish centres who meet the inclusion criteria will be included. The registry will be open until 31 March 2026 to include post-operative morbidity and mortality at 90 days. The number of pancreatic surgeries performed in that centre during the same period will be counted to determine the percentage of robotic pancreatic surgery per centre. Intraoperative complications will be measured according to the Satava classification modified by Halls et al. Postoperative complications will be classified according to the Clavien-Dindo classification and the CCI (Comprehensive Complication Index). Pancreatic fistula, postoperative bleeding and delayed gastric emptying were classified according to the ISGPS classification and biliary fistula according to the ISGLS classification.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Duoneopancreatectomy | – | Device: robotic resection with Da Vinci XiResection of the head of the pancreas |
| Distal pancreatectomy | – | Device: robotic resection with Da Vinci XiResection of the body and the tail of the pancreas |
| Total pancreatectomy | – | Device: robotic resection with Da Vinci XiTotal removal of the pancreas |
| central pancreatectomy | – | Device: robotic resection with Da Vinci Xibody or neck of the pancreas resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who will undergo robotic pancreatic resections
Key inclusion criteria (3 listed)
- robotic pancreatic resections
- Asa I-III
- Signed informed consent
Key exclusion criteria (2 listed)
- Less than 18 years old.
- ASA IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robotic resection with Da Vinci Xirobotic resection with Da Vinci Xi | Device | Distal pancreatectomy, Duoneopancreatectomy, Total pancreatectomy, central pancreatectomy |
Primary outcome
Postoperative complications
Time frame: 90 postoperative days
Clavien-Dindo Classification
Postoperative complications
Time frame: 90 postoperative days
CCI® (Comprehensive Complication Index). 0-100%. 100% represents the death of the patient.
Number of robotic procedures
Time frame: 1 year
Number of robotic pancreatic procedures
4 secondary outcomes
Experience of each group in robotic pancreatic surgery
Time frame: 1 year
Textbook outcome
Time frame: 1 year
Total survival
Time frame: 3 years
Disease-free survival
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No. Due to local law with personal data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic Surgical Procedures and Pancreatic Diseases, run by Hospital General Universitario de Alicante.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 90 postoperative days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.